GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon

GlaxoSmithKline say they ‘started investigating using internal and external teams as soon as we became aware of these claims’. Photograph: Jeff J Mitchell/Getty Images

GlaxoSmithKline, the UK’s largest drug firm, is investigating claims that its staff in Jordan and Lebanon have bribed doctors. The inquiry comes after separate allegations of unscrupulous behaviour by staff in China, Iraq and Poland, with the last two of those cases both emerging earlier this month.

“GSK can confirm we are investigating allegations regarding the activity of a small number of individuals in our operations in Jordan and Lebanon,” the company said in statement. “We started investigating using internal and external teams as soon as we became aware of these claims. These investigations have not yet concluded.”

The crisis at GSK began last July in China, where authorities accused the company of funnelling up to 3bn yuan (£287m) to doctors and officials – as well as supplying them with sexual favours – in efforts to encourage them to use the group’s medicines. The case rocked the pharmaceuticals industry. GSK has admitted that some senior staff may have broken the law and that it is co-operating with investigators.

The company’s reputation was hit again this month, with similar claims of wrongdoing in Iraq and Poland.

The company has launched an investigation of its Iraqi business, while Poland’s Central Anti-Corruption Bureau said on Monday that 13 people had been charged in relation to allegations between 2010 and 2012, although GSK says it found evidence of misconduct by just a single Polish employee, who has been disciplined.

The company insists it does not have a systemic issue with unethical behaviour and says the 161 violations of its sales and marketing policies in 2013 was very similar to rates reported by other pharmaceutical companies. It also says it is making moves to tighten its procedures and has stopped paying doctors to speak on its behalf and tying its sales force’s pay to the number of prescriptions doctors write.

The latest allegations relating to Jordan and Lebanon were first reported in the Wall Street Journal, which cited emails from a person who first contacted GSK in December. The paper said the emails allege that GSK sales representatives bribed doctors to prescribe drugs and vaccines by issuing free samples to doctors that they were allowed to sell on.

Shares in GSK are trading 11% below their level last July, when the China scandal first emerged.

GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon

GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon

GlaxoSmithKline say they ‘started investigating using internal and external teams as soon as we became aware of these claims’. Photograph: Jeff J Mitchell/Getty Images

GlaxoSmithKline, the UK’s largest drug firm, is investigating claims that its staff in Jordan and Lebanon have bribed doctors. The inquiry comes after separate allegations of unscrupulous behaviour by staff in China, Iraq and Poland, with the last two of those cases both emerging earlier this month.

“GSK can confirm we are investigating allegations regarding the activity of a small number of individuals in our operations in Jordan and Lebanon,” the company said in statement. “We started investigating using internal and external teams as soon as we became aware of these claims. These investigations have not yet concluded.”

The crisis at GSK began last July in China, where authorities accused the company of funnelling up to 3bn yuan (£287m) to doctors and officials – as well as supplying them with sexual favours – in efforts to encourage them to use the group’s medicines. The case rocked the pharmaceuticals industry. GSK has admitted that some senior staff may have broken the law and that it is co-operating with investigators.

The company’s reputation was hit again this month, with similar claims of wrongdoing in Iraq and Poland.

The company has launched an investigation of its Iraqi business, while Poland’s Central Anti-Corruption Bureau said on Monday that 13 people had been charged in relation to allegations between 2010 and 2012, although GSK says it found evidence of misconduct by just a single Polish employee, who has been disciplined.

The company insists it does not have a systemic issue with unethical behaviour and says the 161 violations of its sales and marketing policies in 2013 was very similar to rates reported by other pharmaceutical companies. It also says it is making moves to tighten its procedures and has stopped paying doctors to speak on its behalf and tying its sales force’s pay to the number of prescriptions doctors write.

The latest allegations relating to Jordan and Lebanon were first reported in the Wall Street Journal, which cited emails from a person who first contacted GSK in December. The paper said the emails allege that GSK sales representatives bribed doctors to prescribe drugs and vaccines by issuing free samples to doctors that they were allowed to sell on.

Shares in GSK are trading 11% below their level last July, when the China scandal first emerged.

GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon

FDA Investigating Heart Failure Threat Linked To Onglyza

The FDA said today that it was conducting an investigation of a feasible increased chance for heart failure connected with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its producer, BristolMyers-Squibb.)

The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial  in which much more than sixteen,000 sort two diabetics have been randomized to the DPP-four inhibitor saxagliptin or placebo. The trial, presented final year at the European Society of Cardiology and published in the New England Journal of Medication, identified no considerable difference in the composite endpoint of cardiovascular death, MI, or ischemic stroke. However, there was a important excess in hospitalization in the saxagliptin group (three.five% versus two.8%, p=.007).

The FDA mentioned that it has requested trial data from the producer and that it considers present info from the trial to be preliminary. The FDA said that patients must not end taking the drug and must discuss their concerns with a healthcare specialist. The investigation of saxagliptin is part of a broader investigation of the cardiovascular threat of all medicines for kind two diabetes.

Comment: The simultaneous appearance final 12 months of the SAVOR-TIMI 53 trial and the EXAMINE trial with alogliptin (Nesina, Takeda), was a traditional excellent information/poor news setup. On the 1 hand, the overall cardiovascular safety of these diabetes drugs appeared safe. On the other hand, there was no cardiovascular benefit, leaving a lot of to wonder about the true worth of these medication. For now this question hangs in the balance. In the absence of a new big clinical trial especially examining this website link to heart failure it is unlikely that the FDA investigation will be able to supply a definitive reply. But if a thorough investigation turns up far more purpose for concern then these medicines could come under further strain and scrutiny.

FDA Investigating Heart Failure Threat Linked To Onglyza

Justice Department Investigating Aegerion More than Marketing Of New Cholesterol Drug

Aegerion Pharmaceuticals disclosed these days that it is becoming investigated by the US Division of Justice in excess of its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in sufferers with homozygous familial hypercholesterolemia. The drug charges $ 250,000 a yr. The approval came with a box warning about the chance of hepatotoxicity and a strict Risk Evaluation and Mitigation Strategy (REMS) Program which requires certification of well being care suppliers and pharmacies prior to the drug can be prescribed and dispensed.

Last November the company received a warning letter from the FDA after Aegerion’s CEO, Mark Beer, produced feedback on CNBC improperly promoting the drug. Adam Feurstein reported on The Street:

In the course of interviews on CNBC’s ”Fast Money” plan, Beer suggesting remedy with Juxtapid prevents heart attacks and extends the lives of sufferers with familial homozygous hyercholesterolemia (HoFH), a unusual genetic ailment which leads to the build up of incredibly higher ranges of cholesterol in the blood.

The FDA approved Juxtapid based on clinical trials displaying the pill lowers cholesterol levels in HoFH sufferers only. The research did not demonstrate Juxtapid minimizes the danger of heart attacks or aids HoFH patients live longer.

Aegerion stated it will entirely cooperate with the DOJ investigation.

Hat tip: Marilyn Mann

Justice Department Investigating Aegerion More than Marketing Of New Cholesterol Drug